FDA Approves First Nexium Generic

The FDA today approved Ivax Pharmaceuticals’ esomeprazole magnesium delayed-release capsules, the first generic version of AstraZeneca’s proton pump inhibitor (PPI) Nexium, for the treatment of gastroesophageal reflux disease (GERD) in patients aged >1 year.

“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “It is important for patients to have access to treatment options for chronic conditions.”

Esomeprazole capsules have also been approved to reduce the risk of gastric ulcers associated with use of nonsteroidal anti-inflammatory drugs (NSAIDs), treat conditions in which the stomach produces excessive acid, and treat the stomach infection Helicobacter pylori with certain antibiotics.

The most common adverse events reported by trial patients treated with include headache, diarrhea, nausea, flatulence, abdominal pain, sleepiness, constipation, and dry mouth.

The use of esomeprazole has been associated with various stomach problems, including severe diarrhea. Patients who take multiple daily doses of PPIs for extended periods of time may have an increased risk of bone fractures.

Ivax will market its version of esomeprazole in 20 and 40 mg capsules.